The objective is to evaluate the tolerance, safety, pharmacokinetic characteristics and immunogenicity of SHR-A1811 combined with carboplatin and bevacizumab in the treatment of platinum sensitive recurrent epithelial ovarian cancer, and to determine the RP2D of the combination, and preliminarily to evaluate the effectiveness of SHR-A1811 combined regimen in the treatment of platinum sensitive recurrent epithelial ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
SHR-A1811.
Carboplatin.
Bevacizumab.
Oxaliplatin for injection.
Paclitaxel injection.
Doxorubicin hydrochloride liposome injetction.
Adebrelimab injection.
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGDose limited toxicity (DLT)
Time frame: Up to 21 days.
Recommended phase II dose (RP2D)
Time frame: Up to 21 days.
Objective response rate (ORR)
Time frame: Every 9 weeks lasting about one year.
Duration of response (DoR)
Time frame: Every 9 weeks lasting about one year.
Disease control rate (DCR)
Time frame: Every 9 weeks lasting about one year.
Progression free survival (PFS)
Time frame: Every 9 weeks lasting about one year.
Standard response rate (RR)
Time frame: Every 9 weeks lasting about one year.
Overall survival (OS)
Time frame: Approximately 3 years after the last subject enrolled.
Adverse events (AEs)
Time frame: From the first drug administration to within 90 days after the last dose.
Serious adverse events (SAEs)
Time frame: From the first drug administration to within 90 days after the last dose.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.